Off label use and Galvus

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Off Label Use Symptoms and Causes

Normally, your cells grow and die in a controlled way. Cancer cells keep growing without control. Chemotherapy is drug therapy for cancer. It works by killing the cancer cells, stopping them from spreading, or slowing their growth. However, it can also harm healthy cells, which causes side effects.

You may have a lot of side effects, some, or none at all. It depends on the type and amount of chemotherapy you get and how your body reacts. Some common side effects are fatigue, nausea, vomiting, pain, and hair loss. There are ways to prevent or control some side effects. Talk with your health care provider about how to manage them. Healthy cells usually recover after chemotherapy is over, so most side effects gradually go away.

Your treatment plan will depend on the cancer type, the chemotherapy drugs used, the treatment goal, and how your body responds. Chemotherapy may be given alone or with other treatments. You may get treatment every day, every week, or every month. You may have breaks between treatments so that your body has a chance to build new healthy cells. You might take the drugs by mouth, in a shot, as a cream, or intravenously (by IV).

Off Label Use Clinical Trials and Studies

Treatments might be new drugs or new combinations of drugs, new surgical procedures or devices, or new ways to use existing treatments. The goal of clinical trials is to determine if a new test or treatment works and is safe. Clinical trials can also look at other aspects of care, such as improving the quality of life for people with chronic illnesses. People participate in clinical trials for a variety of reasons. Healthy volunteers say they participate to help others and to contribute to moving science forward. Participants with an illness or disease also participate to help others, but also to possibly receive the newest treatment and to have the additional care and attention from the clinical trial staff.

Drug: Vildagliptin followed by Sitagliptin; Drug: Sitagliptin followed by Vildagliptin

Outcome Measures:

The hypoglycemic profile of vildagliptin compared to sitagliptin; Number of hypoglycemic events during vildagliptin treatment compared to sitagliptin treatment.; Duration of hypoglycemic events during vildagliptin treatment compared to sitagliptin treatment; grade of severity of hypoglycemia; Number of severe hypoglycemic events during vildagliptin treatment compared to sitagliptin treatment; Glucose fluctuations during the day under vildagliptin treatment compared to sitagliptin treatment; Impact of hypoglycemic events on ECG abnormalities; Status of pro-inflammatory biomarkers under vildagliptin treatment compared to sitagliptin treatment; Pro-insulin/C-Peptide ratio during vildagliptin treatment compared to sitagliptin treatment.

Rate of loss in glycemic control over time; Time to initial treatment failure; Rate of loss in glycemic control in fasting plasma glucose; Rate of loss in glycemic control in fasting plasma glucose (FPG) during period 2; Rate of loss of beta cell function from baseline to end of study ( 5 years); Number patients with adverse events, death and serious adverse events; Rate of loss in glycemic control in over time; Rate of change in insulin sensitivity from baseline to end of study (5 years)

Change from baseline in glycosylated hemoglobin (HbA1c) at week 24; Change from baseline in glycosylated hemoglobin (HbA1c) at week 12; Change from baseline in fasting plasma glucose(FPG) at week 12 and 24; Change from baseline in postprandial plasma glucose(PPG) at week 12 and 24; Change from baseline in mean amplitude of glycemic excursions (MAGE) by 72-hour continuous glucose monitoring system (CGMS) after 24-week; Percentage of patients reaching the glycemic goal at week 12 and 24; Number of patients with adverse events, serious adverse events and hypoglycemic events

Mean change of HbA1c from Baseline to Month 12; Mean change in fasting plasma glucose (FPG) from Baseline to Month 12; Percentage of patients with HbA1c <7.0%; Percentage of overall drug compliance in 12 months; Percentage patients with adverse events, serious adverse events and death as an assessment of overall safety and tolerability

Percentage of patients who reported at least one symptomatic hypoglycemic event during the 24 week randomized period in both treatment arms; Percentage of patients reaching their glycemic target without hypoglycemic events; Change from baseline in HbA1c to week 24 in both treatment arms; Change from baseline in body weight in both treatment arms; Mean daily insulin dose at Week 24; Percentage of patients with severe and confirmed hypoglycemic events

glycemic variability measured by Mean Amplitude of Average Glucose Excursions (MAGE); glycemic variability measured by Continuous Overlapping Net Glycemic Action (CONGA); Percentage of patients who achieve a decrease equal to or greater than 0.3% in value of HbA1c at week 12 of treatment in comparison to HbA1c value at screening visit; Percentage of reduction achieved in the mean HbA1c at week 12 of treatment in comparison to HbA1c at screening visit; Degree of correlation between MAGE value and hypoglycemia incidence; percentage of patients with incidence of hypoglycemia; Glycemic variability measured by Total Standard Deviation (TSD); Number of patients with adverse events, serious adverse events and death

Percentage of patients with hyperglycemic events evaluated with CGM; Number of hypoglycemia and/or hyperglycemia measured by CGM; Area under the curve (AUC 0-24) of the excursions of glucose values below 60 mg/dl per day; Average of insulin units per day administered during the study; Changes from the baseline in Lipid Profile; Change from baseline in Body weight; Change from baseline in Blood pressure (BP),; Change from baseline in Fasting plasma glucose (FPG),; Change from baseline in Hemoglobin A1C (HbA1c); Change from baseline in Creatinine; Change from baseline in C-peptide; Changes from baseline in alanine aminotransferase (ALT)/aspartate aminotransferase (AST); Changes from baseline in Direct bilirubin; Changes from baseline in Body Mass Index (BMI); Number of patients with adverse events, serious adverse events and death as evaluation of safety and tolerability of coadministration of vildagliptin with insulin

Change from baseline in glycosylated hemoglobin (HbA1c) at 12 weeks between treatment groups; Percentage of patients meeting Responder rates in HbA1c; Change from baseline in Fasting plasma glucose (FPG) at 12 weeks; Number of participants with hypoglycemia and sever hypoglycemia; Number of patients with adverse events, serious adverse events and death

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